1. PCORnet® Overview
September 2017

2. Our national clinical research system is well-intentioned but flawed
We are not generating the evidence we need to answer the healthcare questions that matter most to patients and their doctors.
High percentage of decisions are not supported by evidence
Health outcomes and disparities are not improving
Current clinical research system faces several problems:
Too slow
Too expensive
Doesn't answer questions that matter most to people
What if clinical research was conducted in a completely different way than it is today?
What if instead of spending $30 million to answer a single research question, you could spend $3 million and answer ten?
What if people, researchers, health systems and clinicians were interwoven into the very fabric of our clinical research process, working collaboratively with one another instead of competitively?
Today, I am going to talk with you about PCORnet, the largest effort by the Patient Centered Outcomes Research Institute (PCORI) and representative of a completely different approach to clinical research – one that I think you will agree makes a lot of sense.
Let's start by taking a look at our current clinical research system and how it is faring.
Health care in America is at an exciting precipice
Recent explosion in knowledge and innovation
Yet, at the same time, our traditional clinical research paradigm continues to hold us back
Too slow
Unsustainable surges in cost
Shortfalls in quality and outcomes – many of which aren't answering the questions that matter most to people.
The result is a massive missed opportunity.
Currently, we are not generating the evidence we need to support the healthcare decisions that everyday people and their doctors have to make every day.
Former FDA deputy commissioner Robert Califf agrees - he described a new "ecosystem" for clinical research as key to supporting the efforts by FDA to "put patients first." The traditional clinical trial enterprise, he advised, "ignores these forces at its peril." (

3. PCORI set out to help us improve
What if we could have at our fingertips trustworthy, high-quality data from health systems, people and partnerships to bring people the real-world answers they seek?
What if we could decrease the time it takes to get clinical insights?
With a mission to help people make informed healthcare decisions, and improve healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community, PCORI asked:
What if it didn't have to be this way? What if we could improve the conduct of our clinical research with a national evidence generation system?
Consider the elements of a traditional study that typically impede faster insights
Traditional clinical research typically focuses on a very narrow question.
We build up the study network, and, after a very long period of time, we get the study answered.
Then we immediately break down the network that we've spent so much time building until the next question comes along
It is a redundant system. What if we had an infrastructure that operated more efficiently?
Now let's look at what it is exactly that makes the conduct clinical research so expensive.
Roughly one half of the cost of a traditional clinical study goes into things like monitoring that are not directly getting to the answer we seek.
What if we could eliminate that wasted spend and allocate those dollars to directly the research question? Could we potentially double our insights?
Finally, consider a major inhibitor to the quality of our nation's research: Our clinical studies only represent a narrow slice of the population that we care for – we cannot be sure that our results are applicable broadly across the U.S. population.
But what if we had at our fingertips a trustworthy and diverse knowledge repository from health systems, people and partnerships to bring people the real-world the answers they seek?
What if we could achieve significant cost savings over a traditional clinical study?

4. PCORnet®: the National Patient-Centered Clinical Research Network
An innovative initiative funded by the Patient- Centered Outcomes Research Institute (PCORI), PCORnet is a large, highly representative, national patient-centered clinical research network. Our vision is to support a learning U.S. healthcare system and to enable large-scale clinical research conducted with enhanced quality and efficiency. Our mission is to enable people to make informed healthcare decisions by efficiently conducting clinical research relevant to their needs.
PCORI believed that we COULD, in fact, improve.
It saw these challenges as an opportunity to turn clinical research on its ear by creating PCORnet, a "network of networks" that harnesses the power of the massive amounts of health information. PCORnet is a national evidence generation system in which researchers can now access, under strict privacy and security protections, large sets of health and healthcare data gathered in real-world settings, such as clinics and hospitals.
It is a system where we're constantly asking, answering, and refining questions and improving the standard of care that we're involved with.
A system that not only offers answers to patient and stakeholder questions in a more efficient, less expensive way – but, most importantly, one that offers the RIGHT answers to help people make informed healthcare decisions.
PCORnet is an extension of the PCORI mission, vision and values and PCORnet's patient-centered approach and patient engagement efforts puts people and other healthcare stakeholders in the driver's seat.
Our mission is to enable people to make informed healthcare decisions by efficiently conducting clinical research relevant to their needs. Our vision is to support a dynamic learning U.S. healthcare system and to enable large-scale clinical research conducted with enhanced quality and efficiency.

5. With PCORnet®, we have developed a nationwide functional research network that…
Engages people, clinicians, and health system leaders throughout
Creates infrastructure, tools, and policies to support rapid, efficient clinical research
Utilizes multiple data sources including electronic health records, insurance claims data, data reported directly by people, and other data sources
Enables people and systems to work collaboratively
We created a robust infrastructure that unites clinicians, people, health systems, and all the data that are being generated from patients every day as they have health encounters.
PCORnet links up millions of data points that were previously disparate – not just EHR data, but also data contributed by people – and invites clinicians, health systems and patients to be part of the research process from the outset.
Our goal is to change the research conversation from one directed by researchers to one driven by the needs of patients and other healthcare stakeholders.
Because, when you think about it, isn't this the way clinical research should be?

6. Patients, caregivers and others interested in clinical research provide leadership
Patients and caregivers help identify knowledge gaps by sharing their experiences with the daily burden of disease conditions
Patient and stakeholder engagement, is embodied within the PCORnet Governance Policy.
Patients and caregivers serve as principal investigators for PCORnet studies and networks.
Engagement with participants, caregivers and other stakeholders is a critical ingredient to every aspect of PCORnet both within the Partner Networks and at the broader PCORnet level. Patients participate and provide leadership throughout the network, at every level and stage of research.
The result of all of these engagement efforts in research is significant: more insights that are meaningful to patient communities; answers to questions that have long been ignored by the medical researchers; and a powerful cadre of patients and caregivers.

7. PCORnet® embodies a “network of networks” that harnesses the power of partnerships
PCORnet is made up of three kinds of individual partner networks—Clinical Data Research Networks (CDRNs), Patient-Powered Research Networks (PPRNs) and Health Plan Research Networks (HPRNs)
Our 20 PPRNs are operated and governed by patient groups and their partners
PPRNs are motivated to build an ideal network and play an active role in people-centered clinical research.
CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks.
They securely collect health information during the routine course of care.
Right now, there are 13 CDRNs, which serve millions of Americans across more than 100 health systems.
HPRNs partner with PCORnet CDRNs and PPRNs, engaging in data linkage governance and technical activities in a comprehensive, stepwise approach toward successful linkages of claims and EHR data for use in conducting comparative clinical effectiveness research (CER).
The PCORnet Coordinating Center leads the Network's data and engagement activities, connects with outside research partners, and supports the PCORnet infrastructure. The Coordinating Center is a partnership between PCORI and the Duke Clinical Research Institute, Genetic Alliance and the Harvard Pilgrim Health Care Institute.
20 Patient-Powered Research Networks (PPRNs)
13 Clinical Data Research Networks (CDRNs)
2 Health Plan Research Networks (HPRNs)
1 Coordinating Center
A national infrastructure for people-centered clinical research + + + =

8. PPRNs
ABOUT Patient Powered Research Network (ABOUT Network) University of South Florida ARthritis patient Partnership with comparative Effectiveness Researchers (AR-PoWER PPRN) Global Healthy Living Foundation CCFA Partners Patient Powered Research Network Crohn's and Colitis Foundation Collaborative Patient-Centered Rare Epilepsy Network (REN) Epilepsy Foundation Community and Patient-Partnered Research Network University of California Los Angeles Community-Engaged Network for All (CENA) Genetic Alliance, Inc. COPD Patient Powered Research Network COPD Foundation DuchenneConnect Registry Network Parent Project Muscular Dystrophy Health eHeart Alliance University of California, San Francisco (UCSF)
ImproveCareNow: A Learning Health System for Children with Crohn's Disease and Ulcerative Colitis Cincinnati Children's Hospital Medical Center Interactive Autism Network Kennedy Krieger Institute Mood Patient-Powered Research Network Massachusetts General Hospital Multiple Sclerosis Patient-Powered Research Network Accelerated Cure Project for Multiple Sclerosis National Alzheimer's and Dementia Patient and Caregiver-Powered Research Network Mayo Clinic NephCure Kidney International Arbor Research Collaborative for Health Patients, Advocates and Rheumatology Teams Network for Research and Service (PARTNERS) Consortium Duke University Phelan-McDermid Syndrome Data Network Phelan-McDermid Syndrome Foundation PI Patient Research Connection: PI-CONNECT Immune Deficiency Foundation Population Research in Identity and Disparities for Equality Patient-Powered Research Network (PRIDEnet) University of California San Francisco Vasculitis Patient Powered Research Network University of Pennsylvania
Here is a list of our 20 Patient-Powered Research Networks (PPRNs). PPRNs are made up of patients and/or caregivers who are motivated to build an ideal network and play an active role in patient-centered comparative effectiveness research.

9. CDRNs
Accelerating Data Value Across a National Community Health Center Network (ADVANCE) Oregon Community Health Information Network (OCHIN) Chicago Area Patient Centered Outcomes Research Network (CAPriCORN) The Chicago Community Trust Greater Plains Collaborative (GPC) University of Kansas Medical Center Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) Network Kaiser Foundation Research Institute Research Action for Health Network (REACHnet) Louisiana Public Health Institute (LPHI) Mid-South CDRN Vanderbilt University
National PEDSnet: A Pediatric Learning Health System The Children's Hospital of Philadelphia New York City Clinical Data Research Network (NYC-CDRN) Weill Medical College of Cornell University OneFlorida Clinical Data Research Network University of Florida Patient-Centered Network of Learning Health Systems (LHSNet) Mayo Clinic Patient-oriented SCAlable National Network for Effectiveness Research (pSCANNER) University of California, San Diego (UCSD) PaTH: Towards a Learning Health System University of Pittsburgh Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS) Harvard University
Here is a list of our 13 Clinical Data Research Networks (CDRNs). CDRNs are comprised of many different types of health systems who are partnering to conduct research as a network. Each individual CDRN is building capacity for conducting both randomized trials and observational comparative effectiveness studies using data from their practices and patient populations. These networks involve two or more healthcare systems, and include integrated delivery systems, academic medical centers, and safety net clinics.
With a strong community of patients and caregivers through our PPRNs, as well as health systems through our CDRNs, we have a built a robust network that taps a variety of partnerships and data from multiple sources.

10. HPRNs
HealthCore (a subsidiary of Anthem) Humana – Comprehensive Health Insights (CHI; a subsidiary of Humana Pharmacy Solutions)
The two initial health plans awarded in 2016 are HealthCore and Humana. These two networks partner with PCORnet CDRNs and PPRNs engaging in data linkage governance and technical activities in a comprehensive, stepwise approach toward successful linkages of claims and EHR data for use in conducting comparative clinical effectiveness research (CER).

11. For observational studies
Resulting in a national evidence system with unparalleled research readiness
Pool of patients
Race
Sex
Age
For clinical trials
For observational studies
Missing
White
Non-White
Female
Male
22–64
65+
0–4
65,000,000
128,000,000
5–14
15–21
PCORnet represents: ~128 million patients
who have had a medical encounter in the past 5 years
*some individuals may have visited more than one Network Partner and would be counted more than once
Through data available from our partner networks, PCORnet currently has data from approximately 128 million patients who have had a medical encounter in the past 5 years. (Note that some individuals may have visited more than one network and would be counted more than once). Medical encounters can include many different scenarios, such as a visit to a doctor's office or an Emergency Room visit.
We can drill down and take a closer look at how that breaks down…
By sex
By pool of patients for observational studies or clinical trials
By age
And by race

12. A community of research that unites data from patients, clinicians, and systems
This data is a result of partnerships and collaborations between researchers, patients, clinicians, health systems, and data sources. The information that is available in the Network on the approximately 128 million patients comes from a variety of data sources.

13. The PCORnet Common Data Model
Patient- reported outcomes
Tumor registry
Geocodes
Diagnoses
Demographics
Procedures
Labs
Medication orders
Death data
Patient-generated data
Natural
language processing- derived concepts
Biosamples
Claims
Social determinants of health
To make the data from these 128 million people useful we created a Common Data Model.
The PCORnet CDM is based on the Sentinel Common Data Model, an FDA surveillance platform that incorporates EHR and health plan data. The Sentinel Initiative was built to support rapid data analysis.
PCORnet created the Common Data Model for use among its participating networks. The CDM makes it easier to share information by setting common definitions and organizing data so that: 1) PCORnet can analyze data more quickly. 2) Different platforms can be used by networks to organize their data. 3) Networks can compare their data more easily and efficiently because everyone organizes and defines their data the same way
PCORnet’s Common Data Model (CDM) provides an opportunity for the CDRNs to capture the point of care data included in electronic medical records and store it in the same way for ease of use when conducting research.
As PCORnet evolves and we conduct more research using our CDM, we are refining our data model to reflect what we learn about the types of data you see listed both in green and gray puzzle pieces. The Green pieces—demographics, medications, procedures, etc.—are currently stored in the same way (standardized) across all of our CDRNs and are ready for use in conducting research.  
There is additional data captured in EMRs within our CDRNs, but is has yet to be stored in the same way (standardized).  The types of data found in these gray puzzle pieces—tumor registry, patient generated data from fitbits, claims data,  etc.—are captured by some of the CDRNs, however, there will be variability in the extent of standardization and readiness of the data for use in research.
Genomic results
Data available from several CDRN Network Partners, in the PCORnet CDM and ready for use in research.
Data available at some CDRN Network Partners, may or may not be in the PCORnet CDM and requiring additional work for use in research.

14. Think of all the different ways you can leverage PCORnet®
PCORnet Front Door: Access point to PCORnet resources
Data
Network Request
Study Feasibility Review
Network Collaborator Request
This brings us to the opportunity I would like to share with you today.
We have opened a "Front Door" to this new approach to research.
Through the PCORnet Front Door, we invite potential investigators, patient groups, healthcare organizations, clinicians and clinician groups, government, industry scientists, and sponsors to leverage PCORnet's unique infrastructure and collaborate on patient-centered clinical research. The Front Door is currently accepting requests for Study Feasibility Review, Data Network Queries, Network Collaborators, and/or PCORnet Study Designation.
Here are some examples of how you can use the Front Door:
For a study in development or preliminary data for a grant proposal – for example, how many people with diabetes between the ages of do we have data on? With PCORnet, you can get these answers faster.
To collaborate on study planning and implementation.
Clinical Data Research Networks (CDRNs) and Patient Powered Research Networks (PPRNs) are available to serve as network collaborators.
CDRNs and PPRNs provide complementary strengths, thereby providing access to a wider and richer range of health information to power more efficient clinical research.
PCORnet's feasibility review and/or study designation may be desirable to see if PCORnet is a good match for your research and a great opportunity to reflect the PCORnet brand and its association with high-quality, efficient, and timely people-centered outcomes research. To qualify for PCORnet study designation, a study must: 1. Be people-centered.
2. Include at least one PCORnet network Use quality-checked data standardized to the PCORnet Common Data Model format.
4. Use as many PCORnet resources as possible, when appropriate for the study design.
5. Demonstrate how patients are engaged in the design, conduct, analysis, or dissemination of the research.
PCORnet Study Designation Request

15. You can use PCORnet® for many kinds of research
Pre-research
Feasibility queries
Engagement
Match-making
Interventional studies
Clinical trials
Pragmatic randomized clinical trials
e-Identification
e-Consent
e-Randomization
e-Follow-up
Cluster randomization
Observational studies
Cross-sectional
Epidemiology
Health services
Comparative effectiveness or safety 
Of course, PCORnet is an excellent resource for pre-research and observational studies. But can you really get all the answers that matter most through observational methods?
The answer is, not quite yet.
Invariably, we need randomization to balance all of the confounding factors that we know about and don't know about.
So PCORnet also offers a way to answer questions, especially centered on two or more different strategies of care—or situations in which people have choices available to them—and randomly allocate those choices. Then we can find the answer that will matter for the whole population.

16. We've tested our system’s functionality in multiple research settings
14 PCORI-funded PCORnet demonstration studies are answering critical research questions while also testing the infrastructure and key functional aspects of PCORnet.
Interventional studies
Observational studies
Patient-powered research network (PPRN) studies
Health systems studies Learn more about PCORnet Demonstration Studies
14 PCORnet Demonstration Studies are answering critical research questions while also testing the infrastructure and key functional aspects of PCORnet. Demonstration studies fall into four initiatives:
All of PCORnet research is centered around patient and participant needs and ideas but Patient-Powered Research Network (PPRN) Studies are specifically designed to test the ability to conduct research that addresses the concerns of patient network members via patient-identified research questions that have been prioritized by PPRN community stakeholders and participants. PPRN studies include both observational and randomized controlled trials.
Next are Interventional Studies. The ADAPTABLE aspirin study is PCORnet's first pragmatic, randomized, controlled clinical trial. This study is integrated with routine clinical care and health care delivery and is designed to test the ability to ascertain patients aided by electronic health records (EHRs); work with centralized IRBs and electronic informed consent; and patient recruitment.
Obesity Observational Studies employ an observational design and test the technical and operational aspects of PCORnet's Distributed Research Network (DRN) in addition to standardized capture of a wide range of claims, EHR, and prescription data in the Common Data Model (CDM).
Health Systems Studies test PCORnet's ability to engage health systems leaders and clinicians across Clinical Data Research Networks (CDRNs); to do focused and agile research that leverages the Common Data Model (CDM) and new health system data; and to do analyses rapidly and iteratively with systems leaders to facilitate their development of Learning Health Care Systems. Learning Healthcare Systems, as defined by the Institute of Medicine (IOM), are designed to emphasize a collaborative approach that shares data and insights across boundaries to drive better, more efficient medical practice and patient care.

17. We've also amplified our research power with cross-network collaboration
Collaborative research groups:
Catalyzing multi-network research
Autoimmune and systemic inflammatory syndromes
Behavioral health
Cancer
Cardiovascular health
Diabetes and obesity
Health disparities
Health systems, health policy, and public health
Hospital medicine
Kidney health
Pediatrics
Pulmonary
Each of PCORnet's 11 Collaborative Research Groups (CRGs) are composed of content experts from within the Network focused on generating engaging, high priority research questions to leverage PCORnet's unique infrastructure. While the high-level focus of each CRG is broad, they may also contain Research Interest Groups (RIGs), that are dedicated to more specific research areas.
The CRGs collaborate with stakeholders including patients, caregivers, advocacy groups, providers and funders early on to move research forward more quickly and more efficiently.

18. Here's how the PCORnet® distributed research network works
The Requestor sends a question to the PCORnet Coordinating Center through the Front Door
The Coordinating Center converts the question into a query with an underlying executable code, and sends it to PCORnet partners
PCORnet partners review the query and provide a response, which is sent back through the Front Door to the Requestor
Front Door
Response
Requestor
Question
Let's take a look at how PCORnet works in practice.
If you want to tap PCORnet to answer a research question:
You submit your question to PCORnet
It goes through the Front Door into PCORnet's Coordinating Center, a network of partners who collaborate to lead PCORnet's operations and data activities and maintain its infrastructure. These partners include the Harvard Pilgrim Health Care Institute, Duke Clinical Research Institute, and Genetic Alliance. Our administrators review all requests for use of PCORnet resources and interface with the Distributed Research Network Operations Center (DRN OC) and the Research Committee (RC) to facilitate an efficient review process.
We begin working with the requestor to make sure we know specifically what information is sought.
Then we convert the question to a query
We phrase it in a way that PCORnet's system will understand it to ensure the query gives us the result we need.
We then convert it into SAS code and send it securely to PCORnet network partners, who will run the query against their data and send back the result.
The entire process is performed locally at PCORnet partner networks– the data never moves and remains secure.
PCORnet
Coordinating Center
Query

19. The Front Door is open… take your research to the next level
Through PCORnet Front Door, we invite PCORnet researchers and other investigators, patient groups, healthcare organizations, clinicians or clinician groups, government and industry scientists, and sponsors to collaborate on important patient-centered clinical research studies.
Check it Out!
The power of data is exploding all around us, and now, with PCORnet, we have finally an infrastructure that is allowing clinical research to be conducted as it always should have been…
Uniting clinicians, people, and health systems with the massive amounts of data that are being generated from people in their everyday health encounters.
Driven by the real-world needs of our diverse population – not just a small sliver of the pie
All in a way that is more efficient and less expensive than a traditional research model
Today, we are inviting you to be a part of this transformative research process at the outset.
PCORnet's Front Door is open, and we look forward to seeing you on the other side.

20. Even more enhancements in data are coming soon
Claims data
People-reported data
Medicare data
Registry data
We are constantly looking for new ways to enhance our data and expertise and offer more comprehensive insights.
We are now pulling in new data streams that go far beyond EHRs, including:
Claims data
People-reported data
Medicare data
Registry data.

21. More information on PCORnet®
Website:
PCORnet Commons:
YouTube: PCORI YouTube Playlist
Vimeo: PCORI Vimeo Playlist
PCORnet communications contact:

22. PCORnet® and PCORI About PCORnet
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation's capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at
About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at

23. 23

24. Appendix Additional slides about the CDM
Additional slides about research & case studies
Additional slides about engagement

25. Additional slides about the CDM

26. Underpinned by a Common Data Model Same data are represented differently at different institutions (e.g., Type of Encounter)
SITE 1
Social Work Visit
Allied Health
Office Visit
Nurse Visit
Procedure Visit
Employee Health
Vascular Lab
Sleep Study Visit
SITE 2
Office Visit
Specimen
Postpartum Visit
Clinical Support
Initial Prenatal
Common Data Model
Ambulatory Visit (AV)
Emergency Department (ED)
ED Admit to Inpatient (EI)
Inpatient Hospital (IP)
Non-Acute Inst. Stay (IS)
Other Ambulatory (OA)
Other (OT)
Unknown (UN)
No Information (NI)
SITE 3
Home Care Visit
Office Visit
Therapy Visit
Orders Only
Cardiology Testing
Hospital Encounter
For example, the left side of this slide illustrates how data from three different sites might be represented
Three different ways to represent the same event
On the right, you can see how the Common Data Model standardizes these into a single language
The CDM offers an "apples to apples" comparison of data.
In order to be able to trust results of an analysis, we need to have consistent representations

27. Common Data Model Value Set Common Data Model Value Set
Underpinned by a Common Data Model Same data are represented differently at different institutions (e.g., Race)
SITE 1
Caucasian
African American
Asian
Multiple Race
Blank
SITE 2
101
201
300
401
500
600
SITE 3
American Indian
Asian American
White
Other
Unknown
SITE 1
Caucasian
African American
Asian
Multiple Race
Blank
SITE 2
101
201
300
401
500
600
SITE 3
American Indian
Asian American
White
Other
Unknown
Common Data Model Value Set
01 = American Indian or Alaska Native
02 = Asian
03 = Black or African American
04 = Native Hawaiian or Other Pacific Islander
05 = White
06 = Multiple Race
07 = Refuse to Answer
NI = No Information
UT = Unknown
OT = Other
Common Data Model Value Set
01 = American Indian or Alaska Native
02 = Asian
03 = Black or African American
04 = Native Hawaiian or Other Pacific Islander
05 = White
06 = Multiple Race
07 = Refuse to Answer
NI = No Information
UT = Unknown
OT = Other
For example, the left side of this slide illustrates how data from three different sites might be represented
Three different ways to represent the same event
On the right, you can see how the Common Data Model standardizes these into a single language
In order to be able to trust results of an analysis, we need to have consistent representations

28. PCORnet® Common Data Model domains
Based on FDA Sentinel Common Data Model
Licensed under Creative Commons (open-access, use, and share)
Designed to promote multi-site, patient- centered research
Allows for interoperability
The PCORnet CDM is based on the Sentinel Common Data Model, an FDA surveillance platform that incorporates EHR and health plan data. The Sentinel Initiative was built to support rapid data analysis.
PCORnet created the Common Data Model for use among its participating networks. The CDM makes it easier for communities (in this case the PCORnet networks) to share information with each other by setting common definitions and organizing data so that: 1) PCORnet can analyze data more quickly. 2) Different platforms can be used by networks to organize their data. 3) Networks can compare their data more easily and efficiently because everyone organizes and defines their data the same way

29. Additional slides about research

30. PCORnet® research Types Study designs Data sources
Comparative effectiveness
Population health
Health care delivery
Patient-centered research
Study designs
Randomized controlled trials
Cluster randomized trials
Nonrandomized comparative trials
Longitudinal studies
Surveillance
Cross-sectional
Data sources
Electronic health records
Patient-reported registries
Patient-reported outcomes
Clinical registries
Health plan claims
Of course, PCORnet is an excellent resource for pre-research and observational studies. But can you really get all the answers that matter most through observational methods?
The answer is, not quite yet.
Invariably, we need randomization to balance all of the confounding factors that we know about and don't know about. So PCORnet also offers a way to answer questions, especially centered on two or more different strategies of care—or situations in which people have choices available to them—and randomly allocate those choices. Then we can find the answer that will matter for the whole population.

31. With coverage in every state — PCORnet® represents thousands of conditions
This map depicts the number of PCORI-funded Patient-Powered or Clinical Data Research Networks that have coverage in each state.
As you can see, the span of PPRNs and CDRNs transforms that narrow slice of the population typically represented in a clinical study and offers us something that looks a whole lot more like what we need to examine to get useful answers to our nation's research questions. PCORnet offers coverage in every single state representing thousands of conditions.

32. A few case examples Observational studies Obesity studies
PCORnet Bariatric Study
Short- and Long-term Effects of Antibiotics on Childhood Growth
Pragmatic clinical trials
ADAPTABLE
INVESTED

33. Let's take a look at what PCORnet® can do via a demonstration study
Let's take a look at PCORnet in action
A real life situation: aspirin use
Aspirin has been around for over 100 years, and when you look at the studies, it is actually astonishing how much we still don't know.
Does a higher dose of aspirin lower the risk for mortality and heart attacks? Or does a lower dose improve the risk for bleeding and still have the same benefit? What's the risk/benefit ratio?
Even once that question is answered in general terms, there are more to answer still. Is the risk/benefit ratio the same in men and women? Is it the same in diabetics and nondiabetics? Older or younger patients? African Americans? Caucasian Americans?
We don't know. But with PCORnet, we now have the infrastructure to find out.
Funded by PCORI, The ADAPTABLE trial is leveraging PCORnet to compare the two most commonly prescribed aspirin dosages, 325mg and 81mg, in 20,000 diverse individuals across the United States living with heart disease.
Results of this study will provide answers to the questions that matter to the real-world people taking this medication on a daily basis
Answers that could potentially prevent 88,800 deaths worldwide per year.
ADAPTABLE is also embracing a new paradigm of patient engagement in clinical research. The ADAPTABLE patient partners, Adaptors, work alongside researchers in all aspects of the trial, including designing the protocol, consent form, study portal, and study materials.

34. What if a choice made over the counter prevented…
19,000 deaths/heart attacks or thousands of bleeds annually in the United States

35. Post-MI or HF hospitalization
Age ≥ 65
LVEF < 40% DM
BMI > 30
eGFR < 60
Hx ischemic stroke
Hx PAD
Current smoking
Post-MI or HF hospitalization
*with 1 additional CV risk factor
N = 9300
RANDOMIZED 1:1 DOUBLE-BLIND
ANNUAL VACCINE STRATEGY
High-dose
trivalent
influenza vaccine
Standard-dose
quadrivalent
influenza vaccine
All other CV Rx per treating MD
Followed up to 4 times a year
ANNUAL VACCINATION
to assigned strategy
Duration 3 influenza seasons
+ vanguard season
Primary endpoint:
Death or cardiopulmonary hospitalization 35

36. PCORnet obesity studies
Bariatric study
Aim: to provide accurate estimates of 1-, 3-, and 5-year benefits and risks of three main surgical treatment options for severe obesity
Roux-en-y gastric bypass (RYGB)
Adjustable gastric banding (AGB)
Sleeve gastrectomy (SG)
Childhood obesity study
Aim: compare effects of different types, timing, and amount of antibiotics used in the first two years of life with BMI and obesity at ages 5 and 10
And explore how different factors such as gender, race/ethnicity, geographical location, or characteristics of the mother such as her BMI or type of delivery may impact outcomes

37. PCORnet obesity studies
Bariatric
Antibiotics
# Participating CDRNs 11 10
# Participating institutions 55 38
# Patients
65,088
(64,184 adults; 904 adolescents)
Total children: ~700,000
Cohort members with primary outcome at age 5: ~360,000

38. Additional slides about engagement

39. PCORnet® engagement assessment tool
The engagement assessment tool to ensure people remain central to our work.
The tool is available to the public on the PCORnet Commons
Do you need a tangible way to make your projects more people-centric? The PCORnet engagement assessment tool represents PCORnet’s key values in engagement of people throughout the research cycle. Each principle of engagement identified in this tool has corresponding metrics for ongoing tracking and assessment. This tool is free and available on the PCORnet Commons.

40. Engagement in action: Antibiotics Study
The PCORnet Antibiotics Study formed an Executive Antibiotics Stakeholder Advisory Group (EASAG) to work alongside the scientific team to carry out the study’s objectives.
Members include parents, caregivers, pediatricians, pharmacists, investigators, and advocacy/health systems leaders.
One example of how engagement works is in a PCORI-funded Demonstration Study “Short- and Long-term Effects of Antibiotics on Childhood Growth.” An executive Advisory Group works hand in hand with the Scientific team to carry out the study’s objectives. The end result is a research question, protocol, process, and outcomes that make more sense for real people and are disseminated quickly to communities and families.
The group expertise from numerous viewpoints and adds real-world people perspective by convening routinely to discuss study progress and challenges; producing materials (lay guide) and publishing reports; and developing study tools.

41. Use the PCORnet® Commons!
The PCORnet Commons is a place for people striving to realize the vision of people-centered research.
The goal of the PCORnet Commons is to provide opportunities to increase collaboration, efficiency, and people-centeredness in clinical research.

42. The PCORnet® Commons allows you to:
Connect with real people in PCORnet and beyond
Discover tools, templates, and more
Read about innovative case studies and experiences
Start a group to discuss what's important to your community in real-time
Explore today’s most promising practices in clinical research